MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP FIXED REF FEM SIZER; KNEE INSTRUMENT : ALIGNMENT DEVICES

Model Number 9505-01-263

Device Problem Physical Resistance/Sticking (4012)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

During case the femoral sizer and the femoral posterior referencing femoral rotation guides were not going together easily.Then once we got it on it was extremely difficult to take off.Had to use a hohman to remove the femoral rotation guide.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned devices confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the current complaint sample was manufactured prior to the supplier corrective actions.

• Brand Name: SIGMA HP FIXED REF FEM SIZER
• Type of Device: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10741443
• MDR Text Key: 213236811
• Report Number: 1818910-2020-23382
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295225669
• UDI-Public: 10603295225669
• Combination Product (y/n): N
• PMA/PMN Number: K170748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9505-01-263
• Device Catalogue Number: 950501263
• Device Lot Number: A0808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2020
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1